A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Percent Change From Baseline in Mean Wall Thickness
研究概览
简要总结
This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •CHD, including patients with other CHD risk factors;
- •treated appropriately for dyslipidemia;
- •clinically stable.
排除标准
- •previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
- •recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
- •severe anemia;
- •uncontrolled hypertension;
- •poorly controlled diabetes.
研究组 & 干预措施
Dalcetrapib (RO4607381)
干预措施: Dalcetrapib (RO4607381) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Mean Wall Thickness
时间窗: 24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
时间窗: 6 months
次要结局
- Biomarkers(Up to 24 months)
- Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance(6 months)
- CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure(Throughout study)
- Blood Lipids,Lipoproteins(Throughout study)
- Change From Baseline in Vessel MR Determined Plaque Anatomy(Up to 24 months)